Oesophageal CancerNCT01361750
The Effects of Gastric Tube on the Quality of Life and Nutritional Status After Ivor-Lewis Esophagectomy
A study testing gastric tube in people with Oesophageal Cancer, run by Peking University at 1 site in China.
Trial summary
This study is to investigate the effects of narrowed gastric tube on postoperative nutritional status and the quality of life in esophageal cancer patients treated with Ivor-Lewis esopagectomy in a 12-month follow-up period. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Oesophageal Cancer
- What is being tested?
- gastric tube
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- May 2011to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- esophageal cancer (squamous and adenocarcinoma subtypes)
- eligble for Ivor-Lowis esophagectomy
- expected survival time longer than 12 months
Who cannot join
- palliative resection(non-R0)
- anastomosis leak
- jejunum or colon transversum interponate
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University School of Oncology
Beijing, Beijing Municipality, 100142
About this study
Official title: The Effects of Gastric Tube on the Quality of Life and Nutritional Status After Ivor-Lewis Esophagectomy: A Randomized Control Trial and Physiological Study
This study is to investigate the effects of narrowed gastric tube on postoperative nutritional status and the quality of life in esophageal cancer patients treated with Ivor-Lewis esopagectomy in a 12-month follow-up period.
- Conditions
- Oesophageal Cancer
- Being tested
- gastric tube
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric tubeProcedure or surgery
the stomach will be cut into a narrowed tube-shape conduit
| Study group | Role | What they receive |
|---|---|---|
| gastirc tube group | Experimental | conduit will be perfomed by narrowed gastric tube Receives: Procedure: gastric tube |
| control group | No intervention | conduit will be traditional subtotal stomach without any surgical modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of nutritional status and quality of life before and after operation
Measured: before operation (baseline), 1 month, 6 month and 12 month after operation
Secondary outcomes (1)
change of serum markers and tissue inflammatory status before and after operation
Measured: before operation (baseline), 1 month, 6 month and 12 month after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: higher occurrence of complication than expected for both groups
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oesophageal CancerStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Yue, Peking University
- Investigators
- Yue Yang, M.D., Principal investigator, Peking University Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361750
- Sponsor's protocol ID
- PKU-OES-001
- Status last verified
- Mar 2020
- First submitted
- 24 May 2011
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Gastric Tube on the Quality of Life and Nutritional Status After Ivor-Lewis Esophagectomy: A Randomized Control Trial and Physiological Study
- ClinicalTrials.gov ID
- NCT01361750
- Acronym / sponsor ID
- PKU-OES-001
- Conditions
- Oesophageal Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: higher occurrence of complication than expected for both groups
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 27 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to investigate the effects of narrowed gastric tube on postoperative nutritional status and the quality of life in esophageal cancer patients treated with Ivor-Lewis esopagectomy in a 12-month follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gastirc tube group | Experimental | Procedure: gastric tubeconduit will be perfomed by narrowed gastric tube |
| control group | No intervention | –conduit will be traditional subtotal stomach without any surgical modification |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- esophageal cancer (squamous and adenocarcinoma subtypes)
- eligble for Ivor-Lowis esophagectomy
- expected survival time longer than 12 months
Key exclusion criteria (3 listed)
- palliative resection(non-R0)
- anastomosis leak
- jejunum or colon transversum interponate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gastric tubethe stomach will be cut into a narrowed tube-shape conduit | Procedure or surgery | gastirc tube group |
Primary outcome
change of nutritional status and quality of life before and after operation
Time frame: before operation (baseline), 1 month, 6 month and 12 month after operation
1 secondary outcome
change of serum markers and tissue inflammatory status before and after operation
Time frame: before operation (baseline), 1 month, 6 month and 12 month after operation
Results and safety
The study was stopped early (reason given: higher occurrence of complication than expected for both groups). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yue Yang, M.D. principal investigator
Peking University Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gastric tube in people with Oesophageal Cancer, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: higher occurrence of complication than expected for both groups). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of nutritional status and quality of life before and after operation (time frame: before operation (baseline), 1 month, 6 month and 12 month after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.